Cleared Traditional

K202657 - Javelin Tailor's Bunion Fixation System

K202657 is the FDA 510(k) clearance for Javelin Tailor's Bunion Fixation System by Nvision Biomedical Technologies, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K202657 · Nvision Biomedical Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
91d
Days
Class 2
Risk

K202657 is an FDA 510(k) clearance for the Javelin Tailor's Bunion Fixation System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Nvision Biomedical Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on December 14, 2020 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Nvision Biomedical Technologies, Inc. devices

Submission Details

510(k) Number K202657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2020
Decision Date December 14, 2020
Days to Decision 91 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Nvision Biomedical Technologies
Analaura Villarreal-Berain

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HRS Plate, Fixation, Bone

All 885
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K202657.
ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System
K201259 · Wrightmedicaltechnologyinc · Jan 2021
Baby Gorilla/Gorilla Plating System
K203511 · Paragon 28, Inc. · Dec 2020
DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
K203414 · DePuy Synthes · Dec 2020
PolyLock Plating System
K202959 · Fusion Orthopedics, LLC · Nov 2020
Ortho Solutions Plating System
K202764 · Ortho Solutions UK , Ltd. · Nov 2020
Activ Fuse
K202307 · Newclip Technics · Nov 2020